FDA WARNING_LETTER - Isotron Ireland, Ltd. - September 27, 2007

On September 24-27, 2007, an FDA inspection of Isotron Ireland, Ltd. in Offaly, Ireland, a medical device sterilizer, found its products adulterated under 21 U.S.C. 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Violations included: 1. Failure to establish and maintain procedures for design changes (21 CFR 820.30(i)), using nonconformance processing for specification changes without design controls or validation. 2. Failure to maintain complete complaint investigation records (21 CFR 820.198(e)), with inadequate procedures for device identification, complainant replies, and undefined fields. 3. Failure to adequately validate processes where results cannot be fully verified (21 CFR 820.75(a)), specifically lacking approval signatures and dates on a Validation Report. 4. Failure to review, evaluate, and revalidate processes when changes or deviations occur (21 CFR 820.75(c)), using deviation/concession reports to circumvent design control and validation. 5. Failure to adequately investigate nonconformities (21 CFR 820.100(a)(2)), with indefinite failure investigations and inadequate procedures